← Product Code [GEX](/productcode/GEX) · K130250 # QYAG LASER SYSTEM (K130250) _Palomar Medical Technologies, Inc. · GEX · May 3, 2013 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K130250 ## Device Facts - **Applicant:** Palomar Medical Technologies, Inc. - **Product Code:** [GEX](/productcode/GEX.md) - **Decision Date:** May 3, 2013 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4810 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery - **Attributes:** Therapeutic ## Indications for Use The Palomar QYAG Laser Handpiece is indicated at the 1064 nm wavelength for dark ( i.e. dark blue or black) ink tattoo removal of pigmented lesions, including but not limited to, lentigines, nevi, melasma, Becker Nevus-of-Ota and Café-au-Lait birthmarks. The 532 wavelength is indicated for the removal of light (red, orange, yellow or green) ink tattoos and most pigmented lesions ( e.g. lentigines, ephlides). The 1064/532 blended wavelength is indicated for tattoo removal. ## Device Story The Palomar QYAG Laser Handpiece is an accessory to the Palomar ICON System; it functions as a Q-switched Nd:YAG laser. The device generates laser energy within the handpiece, which is then delivered directly to the patient's tissue. It is intended for use by healthcare professionals in clinical settings for the removal of tattoos and various pigmented lesions. By targeting specific ink colors or pigments with 1064 nm, 532 nm, or blended wavelengths, the device facilitates the removal of unwanted skin markings and lesions. The system console manages power and cooling, while the handpiece serves as the delivery mechanism for the laser energy. ## Clinical Evidence Bench testing only. ## Technological Characteristics Q-switched Nd:YAG laser; accessory to Palomar ICON System (console, cooling, power supply). Operates at 1064 nm, 532 nm, and blended wavelengths. Class II medical device (21 CFR 878.4810). ## Regulatory Identification (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon. ## Predicate Devices - PALOMAR Q-YAG 5 ND: YAG LASER SYSTEM ([K061436](/device/K061436.md)) - HOYA ConBio, Inc. RevLite Q-Switched Nd:YAG Laser System ([K083899](/device/K083899.md)) ## Reference Devices - Quanta System SPA Q-PLUS T+ IPL LASER SYSTEM ([K123168](/device/K123168.md)) - Lutronic Corporation Spectra Laser System ([K113588](/device/K113588.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ 3 2013 MAY # 510(k) Summary QYAG Laser Handpiece This 510(k) summary is being submitted in accordance with 21 CFR 807.92 #### 1. SUBMITTER'S INFORMATION Palomar Medical Technologies, Inc. NAME: 15 Network Drive ADDRESS: Burlington, MA 01803 Phone: (781) 993-2348 Fax: (781) 993-2330 CONTACT: Nicole Brown Regulatory Affairs Specialist II DATE PREPARED: January 21, 2013 #### 2. DEVICE INFORMATION | | TRADE/PROPRIETARY NAME: | Palomar QYAG Laser Handpiece | |--|-------------------------|---------------------------------------------------------------------------------------------------------------| | | COMMON/USUAL NAME: | Q: SWITCHED : Nd:YAG laser | | | CLASSIFICATION NAME: | Laser surgical instrument for use in general and
plastic surgery and in dermatology.
(21 CFR §878.4810) | GEX PRODUCT CODE: #### 3. PREDICATE DEVICES Palomar Medical Technologies, Inc. PALOMAR Q-YAG 5 ND: YAG LASER SYSTEM K061436 HOYA ConBio, Inc. RevLite Q-Switched Nd:YAG Laser System {1}------------------------------------------------ ### K083899 Quanta System SPA Q-PLUS T+ IPL LASER SYSTEM K123168 Lutronic Corporation Spectra Laser System K113588 #### 4. INTENDED USE The Palomar QYAG Laser Handpiece is indicated at the 1064 nm wavelength for dark ( i.e. dark blue or black) ink tattoo removal of pigmented lesions, including but not limited to, lentigines, nevi, melasma, Becker Nevus-of-Ota and Café-au-Lait birthmarks. The 532 wavelength is indicated for the removal of light (red, orange, yellow or green) ink tattoos and most pigmented lesions ( e.g. lentigines, ephlides). The 1064/532 blended wavelength is indicated for tattoo removal. #### 5. DEVICE DESCRIPTION The QYAG Laser handpiece is an accessory to the Palomar ICON System, which is composed of a system console, cooling system, power supply and handpiece. Laser energy is produced in the handpiece and delivered directly to the tissue. #### 6. PERFORMANCE DATA The specifications and indications for use of the QYAG Laser are substantially equivalent to its predicate devices. Thus, do not result in additional safety or effectiveness information. #### SUBSTANTIAL EQUIVALENCE 7. The QYAG Laser Handpiece is substantially equivalent to its predicate devices when used according to its intended use. The information that is provided in this application demonstrates that the QYAG Laser also shares the same technological characteristics as its predicates. {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. ## DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002 May 3, 2013 Palomar Medical Technologies, Inc. % Ms. Nicole Brown Regulatory Affairs Specialist II 15 Network Drive Burlington, Massachusetts 01803 Re: K130250 Trade/Device Name: Palomar QYAG Laser Handpiece Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: GEX Dated: March 01. 2013 Received: March 04, 2013 Dear Ms. Brown: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must {3}------------------------------------------------ Page 2 - Ms. Nicole Brown comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. > Sincerely yours, For Peter D. Rumm -S Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ # Indications for Use 510(k) Number (if known): K130250 ## Device Name: QYAG Laser System The Palomar QYAG Laser Handpiece is indicated at the 1064 nm wavelength for dark ( i.e. dark blue or black) ink tattoo removal, removal of pigmented lesions, including but not limited to, lentigines, nevi, melasma, Becker Nevus-of-Ota and Café-au-Lait birthmarks. The 532 wavelength is indicated for the removal of light (red, orange, yellow or green) ink tattoos and most pigmented lesions (- e.g. lentigines, ephlides). The 1064/532 blended wavelength is indicated for tattoo removal. Prescription Use *X* AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21-CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Neil R Ogden 2013.05.08 15:49:47 -04'00' (Division Sign-Off) for MXM Division of Surgical Devices 510(k) Number *K130250* --- **Source:** [https://fda.innolitics.com/device/K130250](https://fda.innolitics.com/device/K130250) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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